Do you want support or information on one or more of those matters? Our professional professionals will accelerate the entry of your solution to the pharmaceutical/biotech current market.
We’ll operate alongside you to definitely carry out your GMP certification system, ensuring you know how to operate it and you pass your subsequent audit.
Regulation firms searching for pharmaceutical consulting agency experience in the remediation of warning letters, consent decrees, 483’s or import bans
The rules method bordering pharmaceutical organizations is usually tough for even quite possibly the most skilled market veteran to understand. Only one misstep could indicate substantial and lasting outcomes for your company.
Operational Excellence Guide & Lean Production Advisor will allow you to with a holistic method of attain the desired aims of your respective Corporation. Tetrahedron deploys several applications and techniques, All those align the Firm’s tradition, help staff members, and sustain all applied initiatives.
The outcomes of files and on-web-site checks are documented and also the observations and recognized deviations concerning GMP necessities are discussed.
plan have been terrific. During the audit it gave me self esteem realizing we experienced almost everything in line with BRCGS demands.
We've got concluded more than seven-hundred+ Vendor/Supplier Qualification audits. Locally primarily based consultants in wider geography so effective quality of work without language barrier and vacation constraints.
We've got an A rating with BRCGS And that i attribute that to Brian Kellerman and Kellerman Consulting for anything they have got done to website help you our business to obtain the certification. Their initial assessment of our organization, the files, and data delivered to create our
- We be sure that your plant website satisfies your company aims whilst being totally compliant with the newest Fantastic Production Observe restrictions and specifications.
Laura with Kellerman Consulting is simply marvelous. She may be very practical, straightforward to work with and acquired us by our GMP audit using a far better rating than we expected. Also, the organization of every one of the documents Kellerman Consulting supplied us with is superb.
It leads to enhanced sector speed and improved transparency and accountability in the course of a variety of organizations associated with formulation (throughout several dosage varieties), API and biosimilar.
Good Producing Techniques (GMPs) also are generally known as prerequisite courses, or meals basic safety and high quality fundamentals. These are definitely the website and firm distinct principles and day by day actions place into location to maintain products Secure. GMPs check here might be written down or communicated verbally and are typically enforced as a result of High quality Assurance or management staff.
With much more than twenty years of encounter with FDA, Overall health Canada, EU and worldwide regulatory organizations around the globe, Regulatory Compliance Associates® provides leading pharmaceutical consultants. We’re one of several couple of pharma consulting providers which will help you navigate the issues linked to field polices.